Overview of nonmedical. pharmaceutical opioids in Australia. Marissa Veld March 2018, QT Hotel Canberra

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2 Overview of nonmedical use of pharmaceutical opioids in Australia Marissa Veld March 2018, QT Hotel Canberra

3 Introduction What are pharmaceutical opioids? Defining non-medical use Common pharmaceutical opioids, what is misuse, impacts of misuse International context and trends in deaths Consumption patterns National wastewater analysis and Pharmaceutical Benefits Scheme data Illicit and non-medical use (National Drug Strategy Household Survey) Harms and Treatment Ambulance attendances and Hospitalisations Treatment (Alcohol and Other Drug Treatment Services) Policy responses Breaking down the data silos

4 What are pharmaceutical opioids? Pharmaceutical opioids are used to treat acute and chronic pain (including cancer and post operative) and opioid (including heroin) dependence Examples include oxycodone, codeine, fentanyl, methadone. The immediate effects include relief from pain and euphoria (feeling of wellbeing).

5 How do we define non-medical use? Terminology The non-medical use of pharmaceuticals includes the use of overthe-counter or prescription-only drugs for non-therapeutic purposes, or prescription only drugs without a valid prescription Misuse includes non-medical use and the use of pharmaceuticals for genuine medical purposes: without a valid prescription prescribed in excessive quantities or frequencies due to a drug dependence that has developed following medical treatment Can be difficult to determine from data

6 Impacts of non-medical use Short term effects Constipation Nausea Sedation Vomiting Dizziness Slowed breathing Overdose (fatal and nonfatal) Long term effects Tolerance and dependence Decreased cognitive function Occlusion of blood vessels Gastro-intestinal bleeding Mental health problems including depression

7 How big is the problem of non-medical use of opioids? Significant harms in the USA In the USA, in 2015, almost 22,000 deaths or about 62 deaths each day involved prescription opioids (including methadone and synthetic opioids, such as fentanyl and tramadol) In the 12 months between 2014 and 2015, the rate of deaths involving opioids increased 15.6% to 10.4 per 100,000 Sources: Centers for Disease Control (2016) and Rudd et al 2016 Australians appear less aware of the harms 28% of Australians aged 14 and over perceived the non-medical use of pharmaceuticals to be acceptable (up from from 23% in 2013) This is higher than approval of the regular use of tobacco (15.7%) and cannabis (14.5%). Source: 2016 National Drug Strategy Household Survey

8 Rate of drug induced deaths rising Defined as deaths that can be directly attributable to drug use, as determined by toxicology and pathology reports Rate of drug-induced deaths for selected drug classes, Rate per 100, Opioids Depressants Anti-depressants Non-Opioid Analgesics Source: ABS Cause of Death 2016

9 Opioid related deaths In 2016, there were 550 drug-induced deaths from other opioids (includes prescription painkillers such as oxycodone, morphine and codeine but excludes heroin). Number of drug-induced deaths from opioids and heroin, Number 800 Methadone Other opioids Other synthetic narcotics Heroin Source: ABS Cause of Death 2016

10 Trends in consumption National wastewater analysis shows consumption of oxycodone and fentanyl (licit and illicit) exceeds heroin consumption million opioid prescriptions were dispensed under the PBS in up 24% in 5 years. Rates between and increased for Oxycodone (up 58%) Buprenorphine (up 39%) Fentanyl (up 13%) Rate of PBS prescriptions for selected opioids, to Rate per 100,000 Oxycodone Codeine Morphine 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Buprenorphine Methadone Tramadol Fentanyl Source: AIHW analysis of the Pharmaceutical Benefits Scheme (PBS)

11 Self reported non-medical use 2016 National Drug Strategy Household Survey - Self reported information on the use of pharmaceutical opioids for non-medical purposes 3.6% Australians had misused painkillers / opioids in the previous 12 months 3 in 4 (75%) of recent painkillers/ opioids misusers had misused an over the counter codeine product Non-medical use of painkillers / opioids was: Higher for people in their 40s (4.5%); and users were generally older than users of other illicit drugs More prevalent for people living with mental illness (29%) or chronic pain (16%) Purchased over the counter at a pharmacy by around half (52%) of users Reported by around 1 in 10 (10.6%) that they could not stop or cut down if they wanted to

12 Frequency of non-medical use Of Australians who had misused pain-killers / opioids in the previous 12 months, 30% reporting do so daily or weekly, and use was higher for females (33%) Daily or weekly use of selected drugs by sex, 2016 Percent Male Female Persons Pain-killers/ opioids Tranquillisers/sleeping pills Cannabis Meth/Amphetamines Cocaine Source: 2016 National Drug Strategy Household Survey

13 Harms from pharmaceutical opioids increasing Ambulance data No national data available Victorian data show that of the pharmaceutical-related ambulance attendances, 1 in 10 (11%) involved opioid analgesics. 4% were related to opioid pharmacotherapy drugs, like methadone and buprenorphine Source: Alcohol and Other Drugs Statistics, Turning Point Hospitals separations with a principal diagnosis of substance use disorder or harm due to opioids (including heroin, opium, morphine, and methadone) is increasing In , the rate was 37.1 per 100,000 (or 6.6% of drug-related separations) up from 33.0 per 100,000 in Source: National Hospitals Morbidity Dataset

14 Treatment for pharmaceutical opioids Alcohol and Other Drug Treatment Services (AODTS) Increase in the proportion of treatment episodes for most pharmaceutical opioids Of treatment episodes for pharmaceuticals over the last 10 years: Oxycodone increased 3.8 times Codeine increased 2.4 times Other opioids (fentanyl and tramadol) increased 5.2 times Proportion of closed treatment episodes for selected pharmaceutical drugs of concern, to Per cent Codeine Oxycodone Other analgesics Methadone Other opioids Source: Alcohol and Other Drug Treatment Services NMDS

15 Policy responses Restricting access to codeine medicines to prescription only from 1 February 2018 This includes analgesic preparations combined with other pain relief medicines such as aspirin, paracetamol and ibuprofen Real time prescription monitoring Implementation of a national real-time monitoring system of prescription drugs. The system will provide an instant alert to pharmacists and doctors if patients are receiving multiple supplies of prescription only medicines (also referred to as doctor or pharmacy shopping ).

16 Breaking down the data silos AIHW continues to work with stakeholders to collect, analyse and report data on non-medical use of opioids Recent report released on 19 December 2017 International collaboration AIHW and Canadian Institute for Health Information (CIHI) Analysis of comparable data between countries Initial findings show similar trends between countries, report due for release September 2018

17 The impacts of a tamperresistant oxycodone formulation on opioid use and harms in Australia Dr BRIONY LARANCE NDARC, UNSW March 2018, QT Hotel Canberra

18 The National Opioid Medications Abuse Deterrence (NOMAD) study Briony Larance, Louisa Degenhardt, Nicholas Lintzeris, Raimondo Bruno, Amy Peacock, Michael Farrell

19 Disclosures The NOMAD study was funded via an investigatordriven, untied educational grant from Mundipharma Australia. The funder has no role in the design, conduct, analysis, interpretation or decision of what/where to publish. I have also received untied educational grants from Reckitt Benckiser/Indivior and Seqirus for work unrelated to this presentation. The Difference is Research 3

20 OxyContin / Reformulated OxyContin OxyContin = controlled release oxycodone (CRO) Reformulated OxyContin = tamperresistant formulation of CRO (TRF-CRO) One of the most widely prescribed opioids in Australia - concerns re: injection and harms; replaced with a tamper-resistant formulation 1 st April 2014: PBS listing of Reformulated OxyContin 4

21 National Opioid Medication Abuse Deterrence (NOMAD) study: Following the introduction of Reformulated OxyContin 1. Population-level utilisation of oxycodone and other opioids? 2. Extra-medical use of OxyContin? 3. Extra-medical use of other forms of oxycodone or other pharmaceutical opioids? 4. Injection of other illicit drugs? 5. Attractiveness for tampering? 6. Methods of tampering with Reformulated OxyContin evolve/become widespread? 7. Unintended consequences? Degenhardt et al (2015). Evaluating the potential impact of a reformulated version of oxycodone upon tampering, non-adherence and diversion of opioids: The National Opioid Medications Abuse Deterrence (NOMAD) study protocol. Addiction, 110, The Difference is Research

22 Data source/custodian Q1 Population use of opioids Q2 OxyContin use Q3 Other pharm opioid use Q4 Illicit drug injection Q5 Attractiveness Q6 Tampering Q7 Unintended conseq s Population-based indicators of opioid utilisation 1. IMS Health opioid sales data Use, extra-medical use and tampering of oxycodone, other pharmaceutical opioids and of other drugs 2. NOMAD study prospective cohort 3. Illicit Drug Reporting System (PWID) 4. Sydney MSIC data 5. Kirketon Road Centre NSP data 6. Queensland NSP data (QMDS-NSP) Opioid-related morbidity 7. New South Wales (NSW) Ambulance 8. Ambulance Tasmania 9. Hospital separations NSW 10. Hospital separations TAS 11. Emergency department data NSW 12. Emergency department data TAS 13. Royal Adelaide Hospital ED data Opioid treatment and help-seeking 14. PHDAS NSW 15. DASSA OST treatment episodes SA 16. ADIS NSW 17. ADIS TAS

23 Data source/custodian Q1 Population use of opioids Q2 OxyContin use Q3 Other pharm opioid use Q4 Illicit drug injection Q5 Attractiveness Q6 Tampering Q7 Unintended conseq s Population-based indicators of opioid utilisation 1. IMS Health opioid sales data Use, extra-medical use and tampering of oxycodone, other pharmaceutical opioids and of other drugs 2. NOMAD Main study prospective components cohort of the NOMAD study: 3. Illicit Drug Reporting System (PWID) 1. A prospective cohort of 606 people 4. Sydney MSIC data who misuse or tamper 5. Kirketon Road with Centre NSP pharmaceutical data opioids 6. Queensland NSP data (QMDS-NSP) Opioid-related 2. morbidity Illicit Drug Reporting System (IDRS) data, including additional 7. New South Wales module (NSW) Ambulance in 2014 and Ambulance Tasmania 9. Hospital 3. separations Routinely-collected NSW indicator data (~240 individual series): 10. Hospital separations Opioid TAS sales 11. Emergency department Drugs data used NSW by clients at needle and syringe programs (NSP) 12. Emergency department Opioid data overdose/poisoning TAS Help-seeking and treatment 13. Royal Adelaide Hospital ED data Opioid treatment and help-seeking 14. PHDAS NSW 15. DASSA OST treatment episodes SA 16. ADIS NSW 17. ADIS TAS Mortality (not currently available) 7

24 Analytic approach Interrupted time series (ITS*) analyses of opioid sales data and multiple routinely-collected health datasets. * ITS can be used to examine impacts of interventions or shocks (i.e. introduction of Reformulated OxyContin ) while controlling for serial dependence within a given time series. Meta-analyses (weighted z-tests) were conducted to synthesise across data sources providing evidence for a given indicator. 8

25 Q1: Was there a change in the level utilisation of oxycodone? 9

26 Q1: Population-level opioid utilisation Key study outcome Overall pharmaceutical opioid utilisation (OME mgs) Nature of included Total Summary of impact Data sources informing pooled estimates No change Opioid sales data Oxycodone utilisation Total No change Opioid sales data CR oxycodone 40mg Total Opioid sales data CR oxycodone 80 mg Total Opioid sales data CR oxycodone 10/15/20/30mg Total No change Opioid sales data Other oxycodone Total Opioid sales data Other prescribed pharmaceutical opioids Total No change Opioid sales data = significant decrease = significant increase 11

27 Q1: Population-level opioid utilisation Key study outcome Overall pharmaceutical opioid utilisation (OME mgs) Nature of included Total Summary of impact Data sources informing pooled estimates No change Opioid sales data Oxycodone utilisation Total No change Opioid sales data CR oxycodone 40mg Total Opioid sales data CR oxycodone 80 mg Total Opioid sales data CR oxycodone 10/15/20/30mg Total No change Opioid sales data Other oxycodone Total Opioid sales data Other prescribed pharmaceutical opioids Total No change Opioid sales data = significant decrease = significant increase 12

28 Q1: Population-level opioid utilisation Key study outcome Overall pharmaceutical opioid utilisation (OME mgs) Nature of included Total Summary of impact Data sources informing pooled estimates No change Opioid sales data Oxycodone utilisation Total No change Opioid sales data CR oxycodone 40mg Total Opioid sales data CR oxycodone 80 mg Total Opioid sales data CR oxycodone 10/15/20/30mg Total No change Opioid sales data Other oxycodone Total Opioid sales data Other prescribed pharmaceutical opioids Total No change Opioid sales data = significant decrease = significant increase 13

29 Q2 and 3: Were there changes in the injection of OxyContin or other pharmaceutical opioids? 14

30 Q2 and 3: Extra-medical use of pharmaceutical opioids * NSP data includes pooled z-scores across KRC/Clinic 180 last drug injected data, MSIC drug to be injected data and QNSP-MDS drug intending to inject data. Key study outcome Any pharmaceutical opioid injection Oxycodone injection Nature of included Summary of impact Data sources informing pooled estimates Sentinel (PWID) NOMAD cohort Sentinel (PWID) NSP data* Sentinel (PWID) NOMAD cohort Sentinel (PWID) MSIC data CR oxycodone 80mg injection Sentinel (PWID) NOMAD cohort Other pharmaceutical opioid injection (excl. oxycodone) Sentinel (PWID) NOMAD cohort Sentinel (PWID) No change MSIC data

31 Q2 and 3: Extra-medical use of pharmaceutical opioids * NSP data includes pooled z-scores across KRC/Clinic 180 last drug injected data, MSIC drug to be injected data and QNSP-MDS drug intending to inject data. Key study outcome Any pharmaceutical opioid injection Oxycodone injection Nature of included Summary of impact Data sources informing pooled estimates Sentinel (PWID) NOMAD cohort Sentinel (PWID) NSP data* Sentinel (PWID) NOMAD cohort Sentinel (PWID) MSIC data CR oxycodone 80mg injection Sentinel (PWID) NOMAD cohort Other pharmaceutical opioid injection (excl. oxycodone) Sentinel (PWID) NOMAD cohort Sentinel (PWID) No change MSIC data

32 Q2 and 3: Extra-medical use of pharmaceutical opioids * NSP data includes pooled z-scores across KRC/Clinic 180 last drug injected data, MSIC drug to be injected data and QNSP-MDS drug intending to inject data. Key study outcome Any pharmaceutical opioid injection Oxycodone injection Nature of included Summary of impact Data sources informing pooled estimates Sentinel (PWID) NOMAD cohort Sentinel (PWID) NSP data* Sentinel (PWID) NOMAD cohort Sentinel (PWID) MSIC data CR oxycodone 80mg injection Sentinel (PWID) NOMAD cohort Other pharmaceutical opioid injection (excl. oxycodone) Sentinel (PWID) NOMAD cohort Sentinel (PWID) No change MSIC data

33 Q2 and 3: Extra-medical use of pharmaceutical opioids * NSP data includes pooled z-scores across KRC/Clinic 180 last drug injected data, MSIC drug to be injected data and QNSP-MDS drug intending to inject data. Key study outcome Any pharmaceutical opioid injection Oxycodone injection Nature of included Summary of impact Data sources informing pooled estimates Sentinel (PWID) NOMAD cohort Sentinel (PWID) NSP data* Sentinel (PWID) NOMAD cohort Sentinel (PWID) MSIC data CR oxycodone 80mg injection Sentinel (PWID) NOMAD cohort Other pharmaceutical opioid injection (excl. oxycodone) Sentinel (PWID) NOMAD cohort Sentinel (PWID) No change MSIC data

34 Q4: Were there changes in the injection of illicit drugs? 19

35 Q4: Injection of illicit drugs Key study outcome Heroin Amphetamine Nature of included Sentinel Sentinel Summary of impact No change No change Data sources informing pooled estimates NSP data* NSP data* * NSP data includes: pooled z-scores across KRC/Clinic 180 last drug injected data, MSIC drug to be injected data and QNSP-MDS drug intending to inject data. 20

36 Q5: How attractive was Reformulated OxyContin for extra-medical use? 21

37 Q5: Attractiveness Key study outcome Nature of included Summary of impact Data sources informing pooled estimates Median street price per 80mg tablet (CRO vs. TRF-CRO tablet) Sentinel NOMAD cohort Strongly agreed difficult to inject (CRO vs. TRF-CRO) Sentinel NOMAD cohort Intentions to tamper (CRO vs. TRF-CRO) Sentinel NOMAD cohort The Difference is Research

38 Q5: Attractiveness Key study outcome Nature of included Summary of impact Data sources informing pooled estimates Median street price per 80mg tablet (CRO vs. TRF-CRO tablet) Sentinel NOMAD cohort Strongly agreed difficult to inject (CRO vs. TRF-CRO) Sentinel NOMAD cohort Intentions to tamper (CRO vs. TRF-CRO) Sentinel NOMAD cohort The Difference is Research

39 Q5: Attractiveness Key study outcome Nature of included Summary of impact Data sources informing pooled estimates Median street price per 80mg tablet (CRO vs. TRF-CRO tablet) Sentinel NOMAD cohort Strongly agreed difficult to inject (CRO vs. TRF-CRO) Sentinel NOMAD cohort Intentions to tamper (CRO vs. TRF-CRO) Sentinel NOMAD cohort The Difference is Research

40 Q6: Did methods of tampering evolve or become widespread? 25

41 Q5: Evolution and spread of tampering Key study outcome Nature of included Summary of impact Data sources informing pooled estimates Successfully tampered with TRF-CRO (ever) (Wave 2 vs. Wave 3) Sentinel NOMAD cohort Past month tampering with TRF-CRO (Wave 2 vs. Wave 3) Sentinel No change NOMAD cohort The Difference is Research

42 Q5: Evolution and spread of tampering Key study outcome Nature of included Summary of impact Data sources informing pooled estimates Successfully tampered with TRF-CRO (ever) (Wave 2 vs. Wave 3) Sentinel NOMAD cohort Past month tampering with TRF-CRO (Wave 2 vs. Wave 3) Sentinel No change NOMAD cohort The Difference is Research

43 Q7: Were there any unintended consequences (help-seeking, overdose)? 28

44 Q5: Unintended consequences Key study outcome Nature of included Summary of impact Data sources informing pooled estimates Drug overdose (all drugs) Total pop No change Available health data Opioid overdose/poisoning Total pop No change NSW health service data Other drug overdose/poisoning Total pop No change NSW health service data Help-seeking for drugs (all helpline calls) Total pop No change Available ADIS data Help-seeking for opioids Total pop No change NSW ADIS only Help-seeking for other drugs Total pop No change NSW ADIS only Opioid substitution therapy (total) Total pop No change Available OST data Total new treatment entrants Total pop No change NSW PHDAS only Treatment entry oxycodone Total pop NSW PHDAS only Available health data : pooled z-scores across drug overdose/poisonings data from Tasmania EDDC, Tasmania hospital, NSW EDDC, NSW APDC and Royal Adelaide Hospital emergency department data. NSW health service data includes: pooled z-scores on opioid overdose from NSW ambulance data, NSW EDDC and NSW APDC. NSW health service data includes: pooled z-scores on other (non-opioid) drug overdose from NSW ambulance data, NSW EDDC and NSW APDC. Available ADIS data includes: pooled z-scores across NSW and Tasmanian ADIS data. Available OST data includes: pooled z-scores across total number of OST patients in NSW (PHDAS) and South Australia (DASSA).

45 Q5: Unintended consequences Key study outcome Nature of included Summary of impact Data sources informing pooled estimates Drug overdose (all drugs) Total pop No change Available health data Opioid overdose/poisoning Total pop No change NSW health service data Other drug overdose/poisoning Total pop No change NSW health service data Help-seeking for drugs (all helpline calls) Total pop No change Available ADIS data Help-seeking for opioids Total pop No change NSW ADIS only Help-seeking for other drugs Total pop No change NSW ADIS only Opioid treatment program (total) Total pop No change Available OST data Total new treatment entrants Total pop No change NSW PHDAS only Treatment entry oxycodone Total pop NSW PHDAS only Available health data : pooled z-scores across drug overdose/poisonings data from Tasmania EDDC, Tasmania hospital, NSW EDDC, NSW APDC and Royal Adelaide Hospital emergency department data. NSW health service data includes: pooled z-scores on opioid overdose from NSW ambulance data, NSW EDDC and NSW APDC. NSW health service data includes: pooled z-scores on other (non-opioid) drug overdose from NSW ambulance data, NSW EDDC and NSW APDC. Available ADIS data includes: pooled z-scores across NSW and Tasmanian ADIS data. Available OST data includes: pooled z-scores across total number of OST patients in NSW (PHDAS) and South Australia (DASSA).

46 Key findings Qu 1: Decline in OxyContin use (increase in Targin ) Qu 2 and 3: Declines in OxyContin and total oxycodone injection Qu 4: No switching to other opioids or heroin (some differences in MSIC data a special case?) Qu 5: Reduced attractiveness for tampering Qu 6: Tampering increased, but among a small proportion and infrequent use Qu 7: To date, no evidence of other unintended consequences Larance et al (2018) Impacts of a potentially tamper-resistant oxycodone formulation on opioid use and harms in Australia: Main findings from the National Opioids Abuse Deterrence (NOMAD) study. Lancet Psychiatry 31

47 Conclusions Clear impacts among PWID, with reductions in injection of OxyContin /Reformulated OxyContin, no switch to other oxycodone, and no clear evidence of a shift to other opioids or drugs. Did not appear to impact at -level upon opioid use or harms. ADFs may make tampering more difficult, but limited impact addressing issues related to overprescribing, overuse and harms of opioids when taken via the intended route. Larance et al (2018) Impacts of a potentially tamper-resistant oxycodone formulation on opioid use and harms in Australia: Main findings from the National Opioids Abuse Deterrence (NOMAD) study. Lancet Psychiatry 32

48 Acknowledgements Many thanks to the NOMAD study participants, who generously shared their experiences. NOMAD Investigators: Louisa Degenhardt, Briony Larance, Michael Farrell, Nicholas Lintzeris, Raimondo Bruno, Amy Peacock, Robert Ali, Nancy White, Timothy Dobbins Associate Investigators and NOMAD Advisory Committee members: Suzanne Nielsen, Gabrielle Campbell, Lesley Brydon, Malcolm Dobbin, Adrian Dunlop, Angella Duvnjak, Mary Ellen Harrod, Paul Haber, Marianne Jauncey, Robert Kemp, Nghi Phung, Ann Roche and Hester Wilson. Other NOMAD study team members: Ivana Kihas, Toni Hordern, Elena Cama, Dominic Oen, Oluwadamisola Sotade and our team of interviewers in NSW, SA and TAS Special Acknowledgements: Billy Henderson (Mundipharma, NSW, Australia; IMS Health data); Jenny Stafford and Lucy Burns (National Drug and Alcohol Research Centre, NSW, Australia; Illicit Drug Reporting System data); Amanda Roxburgh (National Drug and Alcohol Research Centre, NSW Australia; National Illicit Drugs Indicator Project data); Marianne Jauncey and Allison Salmon (Uniting Medically Supervised Injecting Centre, NSW, Australia; medically supervised injecting centre client visit data); Ingrid van Beek and Karen Chronister (Kirketon Road Centre and Clinic 180, NSW, Australia; last drug injected data for two inner-sydney needle and syringe programmes); Robert Kemp and Abhilash Dev (Queensland Health, Queensland Government, Australia; Queensland Minimum Data Set for the Needle-Syringe Programs); Peter Mansfield (Department of Health and Human Services, Tasmania Government; Tasmanian Emergency Department Data Collection data/admitted Patient Data Collection data); Orson Rapose (Turning Point, VIC, Australia; Alcohol and Drug Information Service data for Victoria, Australia); Ambulance Australia, Tasmania Department of Health and Human Services, Tasmania Government (Tasmanian Ambulance data); Ian Richards (Community Based Treatment Division, Drug and Alcohol Services South Australia, SA Health, South Australia, Australia; Alcohol and Drug Information Service data for South Australia, and opioid substitution therapy data from Drug and Alcohol Services South Australia); Pia Salmelainen (New South Wales Ministry of Health; Pharmaceutical and Drugs of Addiction System data); David Lester (St Vincents Hospital, New South Wales; New South Wales Alcohol and Drug Information Service data); Francine Smith (Tasmanian Department of Health and Human Services, TAS, Australia); and the National Clinical Terminology Service from the Australian Digital Health Agency for assistance with SNOMED mapping and codes. Thanks also to the Centre for Epidemiology and Evidence, New South Wales Ministry of Health for preparation and provision of data from (a) the Emergency Department Records for Epidemiology and (b) Combined Admitted Patient Epidemiology Data held by the New South Wales Ministry of Health Secure Analytics for Population Health Research and Intelligence. NHMRC fellowships: Briony Larance, Louisa Degenhardt, Amy Peacock Mundipharma: Untied educational grant 33

49 Thank you! Briony Larance Senior Research Fellow (NHMRC ECF) NDARC, UNSW Australia : (02) : b.larance@unsw.edu.au 34

50 SafeScript Victoria s Real-Time Prescription Monitoring system Australian and New Zealand School of Government Breaking the Data Silos Conference 27 March 2018

51 Harms from high-risk prescription medicines Deaths in Victoria Prescription medicines Illicit drugs Road toll coronial findings since 2012 where Coroners have called for a monitoring system in Victoria All key health and consumer organisations strongly advocate a monitoring system

52 SafeScript: sharing data between clinicians Doctor (or other prescriber) Patient visits doctor Doctor checks the system Doctor decides whether to prescribe or not If safe, doctor writes a prescription DHHS has access to SafeScript to oversee compliance and the appropriate supply of medicines Pharmacists Patient presents prescription at pharmacy Pharmacist checks system Pharmacist decides whether to dispense or not If dispensed, record captured in the system

53 Supporting activity Support for Clinicians and Consumers Training for prescribers and pharmacists Public Awareness Campaign GP Champions Initiative Minor enhancements to the Alcohol and Other Drugs (AOD) treatment sector This is in addition to broader activity being implemented through Victorian DHHS Significant new investment in AOD treatment sector AOD Workforce Strategy and development projects

54 Implementation Details Scope of medicines to be monitored through SafeScript All Schedule 8 Medicines Some Schedule 4 medicines including all benzodiazepines Mandatory use by prescribers and pharmacists After transitional period of 18 months Implementation Approach Implementation in a study area will commence in late 2018 Review of deployment activities before further roll-out

55 Stakeholders influence An Expert Advisory Group provides advice about key policy and implementation aspects of SafeScript that affect patients and health professionals. Early feedback from the EAG and other key stakeholders indicated a need for a system with: minimal interruption to clinical workflow integration with existing prescribing and dispensing software minimal or no additional data entry required by clinicians This led to a reconsideration of the available technology Move to seek more contemporary data and technology solutions

56 Being smarter about data and technology Sourcing Data Technology- Scalability and Performance Integration into health professionals workflow Patient identification and matching Victorian RTPM SafeScript architecture provides a more efficient approach to sourcing data by leveraging existing digital health assets to integrate with eprescription Exchange Services (PES) SafeScript architecture leverages more contemporary technology on a cloudbased platform which can scale indefinitely to support any future needs including growth in prescription volumes and number of users without requiring any significant system redevelopment. Capability to reticulate notifications to health professionals to ensure integration into health professionals workflow Additionally, the solution will provide an application programming interface (API) which will allow for seamless integration with prescriber and pharmacy software. The Victorian approach provides a real-time data enrichment function that will enable retrieving the patient IHI through calls to the HI services. Therefore, the patient identification processes for will be more reliable. National integration As other jurisdictions develop monitoring systems, coordination with their data will provide information about cross-border supply of high risk medicines. Meanwhile, our legislative framework enables us to capture data about all prescribing and dispensing to Victorian patients.

57 SafeScript data Patient name Patient address Demographics Prescriber name and address, specialty Number of prescribers Pharmacy name and address Number of pharmacies Monitored drug(s) Drug dose Drug combinations Number of prescriptions per patient

58 Current Progress and Activity The Bill to establish the legislative framework for the system recently passed through Victorian Parliament Draft regulations and Regulatory Impact Statement (RIS) was released for consultation Fred IT Group has been appointed to build the system Working with a consortium, comprising all Victorian Primary Health Networks and NPS MedicineWise, to develop training for prescribers and pharmacists Market research for concepts for the Public Awareness Campaign Planning for implementation including communication and stakeholder engagement

59 For more information STAY ON THE SAFE SIDE